Pharmacoepidemiologist M / F

AIXIAL GROUP; Lyon; Sur place; EUR 45 000 - 70 000; Plein temps

Résumé du poste

Join a forward-thinking company at the forefront of clinical research, where your expertise as a Pharmacoepidemiologist will help shape the future of healthcare. This role offers the opportunity to work collaboratively in a dynamic international environment, contributing to impactful projects that enhance patient safety and regulatory compliance. With a strong commitment to career development, diversity, and inclusion, you will be empowered to grow both professionally and personally. If you are passionate about making a difference in life sciences, this is the perfect opportunity for you.

Prestations

Career development opportunities

Mentorship and coaching

Diversity and inclusion initiatives

Flexible working environment

Qualifications

• Master's degree or equivalent in public health or epidemiology.
• 5+ years of experience in a similar role.

Responsabilités

• Ensure scientific quality and operational follow-up of studies.
• Manage epidemiological evaluations and compliance with submission timelines.

Connaissances

Pharmacoepidemiology

Project Management

Statistical Analysis

Scientific Literature Review

Regulatory Compliance

Fluency in English

Fluency in French

Formation

Master's degree (BAC+5)

PhD

PharmD

Description du poste

You are a highly skilled professional with a passion for the world of life sciences and clinical research. You want to thrive in a dynamic and collaborative international environment where your expertise can directly impact people's lives. Come and join Aixial Group to contribute to shaping the future of clinical research!

We are currently looking for a Pharmacoepidemiologist (M/F) to carry out the following tasks (non-exhaustive list):

1. Ensuring the scientific quality of entrusted studies (protocols, statistical analysis plans, study reports, result interpretation, study documents, project meetings).
2. Ensuring the operational follow-up of entrusted studies (management of service providers, management of internal procedures related to studies).
3. Managing the epidemiological evaluation of safety signals (review and analysis of scientific literature).
4. Contributing to updates of crisis management plans, responses to health authority queries, and participation in cross-functional meetings (with pharmacovigilance, medical affairs, and regulatory affairs).
5. Writing summaries in a confidential context towards regulatory authorities.
6. Carefully following operational procedures while respecting deadlines.
7. Analyzing pharmacoepidemiological scientific literature for safety signals / SER, RMP, PBRER / PSUR.
8. Reviewing protocols, statistical analysis plans, and study reports for PASS (Post-Authorisation Safety Study).
9. Ensuring compliance with submission timelines of PASS study documents to regulatory authorities.

Your profile:

• You hold a Master's degree (BAC+5), PhD, PharmD with a specialization in public health, epidemiology, or an equivalent field of study.
• You have at least 5 years of experience in a similar position.
• You can manage projects and work transversally in multidisciplinary teams: medical, regulatory, marketing, etc.
• You possess good listening skills and diplomacy.
• You are fluent in English (written and spoken).
• Professional or fluent level in French would be a plus.

Who are we?

• We are one of the world’s leaders in CRO (Contract Research Organization), committed, experienced, and flexible enough to deliver efficient clinical trials.
• We collaborate with global pharmaceutical, biotech, cosmetic, medical device, and other companies, providing innovative and scalable solutions.
• Operating in 10 countries across 3 continents, we bring together over 1000 talented professionals dedicated to making a positive impact in the life sciences industry.
• Part of the ALTEN Group since 2014, we are continuously exploring new opportunities to expand our global activities.

Why join us?

• Make a positive impact and be at the forefront of projects: contribute to groundbreaking advancements in clinical research that positively affect millions of lives worldwide.
• Career development: We value our people and are committed to empowering our team, fostering growth, flexibility, and teamwork. At Aixial Group, you will receive coaching and mentorship to support your professional and personal growth.
• Our commitment to diversity, equality, and inclusion: We aim to create a respectful workforce where individual differences are recognized and valued, and where each employee can give their best. Gender equality is central to our development strategy.

Aixial Group continues to grow and recruit in the clinical trial professions. Join us and visit our website to stay updated on our latest opportunities.